A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination With Carboplatin Plus Pemetrexed Versus Platinum Plus Pemetrexed or Nivolumab Plus Ipilimumab in Participants With Unresectable Pleural Mesothelioma (eVOLVE-Meso)
AstraZeneca
Summary
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.
Description
Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of platinum+Pemetrexed or Nivolumab+Ipilimumab, based on their histology.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Participant must be ≥ 18 years at the time of screening * Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid) * Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy) * WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS\>1) over the previous 2 weeks prior to day of first dosing * Has measurable disease per modified RECIST1.1 * Has adequate bone marrow reserve and organ function at baseline Key Exclusion Criteria: * As judged by th…
Interventions
- DrugVolrustomig
MEDI5752: Administered as IV infusion
- DrugPemetrexed
Alimta: Administered as IV infusion
- DrugCarboplatin
Paraplatin: Administered as IV infusion
- DrugCisplatin
Platinol: Administered as IV infusion
- DrugNivolumab
Opdivo: Administered as IV infusion
- DrugIpilimumab
Yervoy: Administered as IV infusion
Locations (178)
- Research SitePhoenix, Arizona
- Research SiteDuarte, California
- Research SiteSanta Rosa, California
- Research SiteAurora, Colorado
- Research SiteJacksonville, Florida
- Research SiteAtlanta, Georgia